The International Council for Harmonisation (ICH) Q2(R2) and Q14 guidelines, finalized in late 2023, outline strategies for analytical procedure development, validation, and lifecycle management. As global implementation progresses, ISPE’s PQLI® Analytical Method Strategy Team surveyed industry stakeholders in mid-2024 to assess readiness, identify opportunities, and highlight areas...
Simplified approaches that enable changes to analytical procedures over their lifecycle are needed to allow continual improvements and adaptations due to technological obsolescence and other challenges. This article reflects on the positive impact that the recent ICH Q14 guidance can have on facilitating these changes. Five examples are provided that are based on scenarios in which analytical...
Pharmaceutical and biotechnology companies employ platform analytical procedures in the development stages of their synthetic and biological drug products and are beginning to leverage them for commercial products. This shift is supported by the acceptance of platform procedures in the recently adopted ICH Q2(R2) and ICH Q14. Six case studies are shared in this article to highlight how...
ISPE’s Analytical Method Strategy/ICH Q2(R2) & Q14 team, a working group within ISPE’s Product Quality and Lifecycle Implementation (PQLI)® Committee, to lead ISPE’s comments on the ICH documents to regulatory authorities.
